COVID-19 Rapid Test Recalled as It Is Only Approved for Research in Labs

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Celltrion DiaTrust COVID-19 Ag Rapid Test Recall Overview:

• Who: Celltrion USA is recalling lots of the POC DiaTrust COVID-19 Ag Rapid Test labeled for research use only.
• Why: The tests were distributed to customers unlikely to have used the tests for research use only and who may not be trained to do nasopharyngeal swab samples safely.
• Where: The recall is nationwide.

A COVID-19 rapid test that requires a specimen sample taken deep through the nose at the back of the throat has been recalled as it was accidentally distributed to people outside of laboratories. 

The U.S. Food and Drug Administration issued the recall for up to 119,600 lots of Celltrion DiaTrust COVID-19 Ag Rapid Test labeled for research use only on its website Mar. 23. The recall was initially issued Dec. 2, 2021, by the company. 

According to the recall, the rapid test is labeled for research use only and not for use in diagnostic procedures; however, it was distributed to customers who would be unlikely to have used these tests for research use only.

The tests require use of the nasopharyngeal collection method, which collects a sample from the upper part of the throat behind the nose. The method uses a swab to go through the nose to the back of the throat and should only be performed by a healthcare practitioner.

The recall says customers who received the tests “may not have the proper training to safely collect nasopharyngeal swab samples from people.”

“There are serious injury risks if someone who is not trained to collect a nasopharyngeal swab sample attempts to do so,” the recall notice says.

Celltrion COVID-19 Tests Also Use Labeling Outside of Authorized Use

The Celltrion DiaTrust COVID-19 Ag Rapid Tests also use labeling that is outside of authorized use, the recall notice says.

“Although there have been no reports of injuries, adverse health consequences or death associated with the use of these affected products, false positive or false negative results from improper use of these tests could lead to further exposure of uninfected individuals to SARS-CoV-2 virus,” the recall states. 

The company is not currently facing legal action over the recall, but Top Class Actions follows recalls closely as they sometimes end in class action lawsuits.

If customers received the POC Celltrion DiaTrust COVID-19 Ag Rapid Test labeled research use only, they should not be used for clinical diagnosis of COVID-19 or patient management, the recall states. 

Test users and health care providers should discontinue clinical use of the tests, quarantine them and contact Celltrion USA for information on how to return the unused product or, alternatively, “discard or destroy” it.

Earlier this month, Celltrion US issued a recall for its Celltrion DiaTrust COVID-19 Ag Rapid Tests over concerns they have an unauthorized shelf life and can record false positive test results. 

The company said it is recalling the tests after receiving numerous reports of false positive test results from individuals trying to find out if they have COVID-19, according to the recall. 

What do you think of these Celltrion COVID-19 test recalls? Let us know in the comments! 

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